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Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00905333
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : December 7, 2010
Sponsor:
Collaborators:
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®

Condition or disease Intervention/treatment Phase
Healthy Drug: Candesartan (test) Drug: Felodipine (test) Drug: Candesartan Cilexetil Drug: Felodipine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.
Study Start Date : October 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
 Drug: Candesartan (test)
16 mg oral tablet, single dose

Drug: Felodipine (test)
5 mg oral extended release tablet, single dose

Drug: Candesartan Cilexetil
16 mg oral tablet, single dose
Other Name: Atacand®

Drug: Felodipine
5 mg oral extended release tablet, single dose
Other Name: Splendil®


Outcome Measures
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Primary Outcome Measures :
  1. Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. [ Time Frame: 76 blood samples per subject ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)

Exclusion Criteria:

  • Not healthy
  • Chronic drug intake
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905333


Locations
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Brazil
Research Site
Itatiba, SP, Brazil
Research Site
Americana, Brazil
Sponsors and Collaborators
AstraZeneca
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculty of Pharmaceutical Sciences of Ribeirão Preto - Bioequivalence Center
Investigators
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Principal Investigator: Eduardo Abib Junior, MD Scentryphar Clinical Research
Study Chair: Moises L. P Vanuncci, MD Scentryphar Clinical Research
More Information
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Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00905333    
Other Study ID Numbers: D2452L00021
IMPACT 15381
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010
Keywords provided by AstraZeneca:
pharmacokinetics
candesartan
felodipine
test formulations
Atacand®
 Splendil®
healthy volunteers
blood samples
after meal intake interaction
Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.
Additional relevant MeSH terms:
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Felodipine
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
 Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents